Pharma

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  FiercePharma

• Otsuka puts off broadening use of Abilify

  Tracy Staton

  20 Nov 2009 | 8:19 am

  Otsuka Pharmaceutical yanked its European application for broader use of Abilify; it had asked the EMEA for permission to market the antipsychotic drug as a treatment for depression. Report

• Pharma credit ratings to suffer through 2012

  Tracy Staton

  20 Nov 2009 | 8:17 am

  For several years now, Big Pharma has been scrambling to replace the revenues it's set to lose as blockbuster meds fall off patent. Companies have tried megamergers, licensing deals and generic buyouts. They've targeted a welter of emerging markets for growth. And they've cut costs to retrench in the meantime.  But that hasn't been enough for Moody's Investors Service. According to the Associated Press, the ratings firm issued a negative opinion on the entire industry, saying that drugmaker credit ratings will remain under pressure until 2012. That's because, despite all their…

• Is bad-news Genzyme paying CEO too much?

  Tracy Staton

  20 Nov 2009 | 8:08 am

  When a company hits the skids, fingers start to point. And lately, fingers have been pointing pretty forcefully at Henri Termeer (photo), CEO of the ill-fated company Genzyme. Naturally, inquiring minds want to know how Termeer has fared financially as his company has been suffering. The answer? Not too shabbily. Termeer got about $50.8 million in compensation over the past three years, BNet reports. That's about $14 million a year at a company that posts some $4 billion in annual sales. Companies many times that large often don't pay their CEOs that much. And that's even when shareholders…

• Plavix vs. Effient shows payer power

  Tracy Staton

  20 Nov 2009 | 7:56 am

  It's not revolutionary to suggest that the blockbuster drug model is passé. Industry watchers have been theorizing for some time that specialty drugs are where it's at, that personalized healthcare is the future, that all the easy disease targets have already been hit. Pharma can no longer expect--or even hope--that new blockbusters will save them from mega-patent expirations. But In Vivo has taken a detailed look at a quite different pressure on the blockbuster model: the payer. Exhibit A is the current head-to-head battle between the old standby clotbuster Plavix, set to go off…

• Goldman: China's No. 1 pharma will be Pfizer

  Tracy Staton

  20 Nov 2009 | 7:38 am

  Which drugmaker is best positioned to grow in China? We might have said Bayer, considering it has a head start with sales teams and products in place, even in the hinterlands. But Goldman Sachs would disagree. The investment bank did a review of Pfizer and decided--you guessed it--that the world's biggest Big Pharma firm is ahead of every other Western drugmaker in China. Emerging markets are the apple of every pharma's eye these days. And because of its huge population and its current efforts at healthcare reform, China is attracting lots of that attention. According to ChinaBio Today…

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  Google News: Pharma

• Moody's on Pharma: Outlook Is Negative, But it Could Be Worse - Wall Street Journal (blog)

  20 Nov 2009 | 12:35 pm

  Moody's on Pharma: Outlook Is Negative, But it Could Be WorseWall Street Journal (blog)Pharma companies look like they have dodged the worst-case scenarios under the US health-care overhaul. While the costs to the industry are still being

• Aurobindo Pharma aims to treble revenue by 2014 - Livemint

  20 Nov 2009 | 10:25 am

  Aurobindo Pharma aims to treble revenue by 2014LivemintHyderabad: Aurobindo Pharma Ltd aims to cross $2 billion in revenue, three times what it is now, over the next four years by March 2014, primarily driven by Goldman: China's No. 1 pharma will be PfizerFiercePharmaPfizer Executive:In Talks To Expand Licensing Pact With AurobindoCNNMoney.comPfizer's Generics Business Takes ShapeWall Street Journal (blog)all 7 news articles »

• Pharma group probes launch of female sex drive drug - Deutsche Welle

  20 Nov 2009 | 8:51 am

  Pharma group probes launch of female sex drive drugDeutsche WelleFlibanserin started as an anti-depressant, but after women in clinical trials reported an increased libido, the German pharma group Boehringer Ingelheim and more »

• EU Panel: Affirm Benefits Of Celvapan, Focetria, Pandemrix - CNNMoney.com

  20 Nov 2009 | 5:41 am

  Javno.hrEU Panel: Affirm Benefits Of Celvapan, Focetria, PandemrixCNNMoney.comNenad (lisuride), from Axxonis Pharma AG, intended for the treatment of the signs and symptoms of Restless Legs Syndrome. -* Docetaxel TEVA (docetaxel) European Medicines Evaluation Agency (emea) - EMEA press release - Meeting DeHavilland (press release) (subscription)all 15 news articles »

• Senate health bill pharma-friendly on biologics, price controls - Medical Marketing and Media

  19 Nov 2009 | 1:23 pm

  New York TimesSenate health bill pharma-friendly on biologics, price controlsMedical Marketing and MediaThe Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity Congress: Timelines and calendarsmsnbc.comReid uncertain of tally as healthcare bill heads for rare Saturday voteThe HillWhat if Health Care Reform is Defeated?OpEdNewsall 4,856 news articles »

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  MedicalNewsToday: Pharma Industry

• Daschle Still Making Voice Heard On Health Care

  20 Nov 2009 | 5:00 am

  The Hill reports that former Senate Majority Leader Tom Daschle helped Obama Administration officials strategize to win health care reform votes from Senators on Capitol Hill Wednesday.

• Lawmakers Call For Inquiry Into Pharmaceutical Company Price Hikes

  20 Nov 2009 | 5:00 am

  Reuters: "Congressional Democrats are seeking government investigations into recent price increases of brand-name prescription drugs, as Congress finalizes an overhaul of the healthcare system.

• Op-Eds: HIV Travel Ban; Improving Sanitation; Counterfeit Drugs

  20 Nov 2009 | 5:00 am

  'Blot' On U.S. HIV/AIDS Leadership Removed A "blot" on U.S. HIV/AIDS leadership "ended last month when President [Barack] Obama lifted the prohibition" that kept HIV-positive foreigners from visiting the U.S. or seeking residency, according to a

• Pfizer, DNDi Partner To Identify NTD Drugs; Sanofi-Aventis, Medicines For Malaria Launch Drug Study

  20 Nov 2009 | 4:00 am

  Pfizer and the Drugs for Neglected Diseases Initiative (DNDi) on Wednesday announced plans to team up in an effort to identify new drug candidates for the treatment of three tropical diseases, the Associated Press/Business Week reports. The scientists will test the efficacy of Pfizer drug candidates against sleeping sickness, visceral leishmaniasis, and Chagas disease.

• FDA Issues 22 Warning Letters To Web Site Operators

  20 Nov 2009 | 3:00 am

  The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

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  Drugs.com - Daily Med News

• 'Hobbits' Were a Distinct Species, Study Concludes

  20 Nov 2009 | 11:01 am

  FRIDAY, Nov. 20 --The ancient dwarfs known as "hobbits" weren't humans shrunk down by disease, scientists now say, but instead, they were a distinct human species. The researchers came to their conclusion by statistically analyzing a female...

• Blood Test Could Boost Clarity of Breast MRI Results for Some

  20 Nov 2009 | 9:00 am

  FRIDAY, Nov. 20 -- Using a blood test to pinpoint the optimal timing of breast MRI scans in women with irregular menstrual cycles could reduce the need for repeat scans, U.S. researchers say. Previous studies have found that performing breast MRI...

• Discovery Boosts Boys' Prospects for Post-Cancer Fertility

  20 Nov 2009 | 9:00 am

  FRIDAY, Nov. 20 -- New research suggests it may become possible for pre-pubescent boys stricken by cancer to prepare for the future when they may be infertile but still want to become natural fathers. Scientists in the Netherlands found that...

• Even Smokers Support Bans at Work

  20 Nov 2009 | 9:00 am

  FRIDAY, Nov. 20 -- Most smokers around the world support workplace smoking bans, according to a new study. Researchers surveyed more than 3,500 employees who smoke and more than 1,400 employers (smokers and nonsmokers) in the United States and 13...

• Unraveling the 'Mad Cow' Mystery

  20 Nov 2009 | 9:00 am

  FRIDAY, Nov. 20 -- Researchers may be moving closer to better treatments for bovine spongiform encephalopathy, better known as mad cow disease, and the related condition called Creutzfeldt Jakob disease. A protein called Glypican-1 is crucial to the...

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  Drugs.com - Pharma Industry News

• Antitrust Lawyer Files Suit to Stop Pfizer Merger

  20 Nov 2009 | 7:39 am

  Antitrust Lawyer Files Suit to Stop Pfizer Merger [The Day, New London, Conn.] From Day, The (New London, CT) (November 20, 2009) Nov. 20--A prominent San Francisco antitrust attorney said Thursday he has filed a request in federal court for a...

• The Botax? Nip/Tuck Levy to Help Health Care Plan

  20 Nov 2009 | 6:47 am

  From Associated Press (November 20, 2009) WASHINGTON--They call it the "Botax." The White House and Senate Democrats have turned to a proposal to tax breast implants, tummy tucks, wrinkle-smoothing injections and other procedures as they search for...

• Moody's Gives Negative View on Pharma Credit

  20 Nov 2009 | 6:47 am

  From Associated Press (November 19, 2009) NEW YORK--Moody's Investors Service issued a negative opinion on the pharmaceutical industry Thursday, saying drugmaker credit ratings will be under pressure until early 2012 because they won't be able to...

• Retiring Lilly Research Exec Steven Paul Gets $2 Million in Severance [The Indianapolis Star]

  20 Nov 2009 | 6:41 am

  From Indianapolis Star (IN) (November 20, 2009) Nov. 20--The top research executive at Eli Lilly and Co. will receive a $2 million cash severance payment and be credited with extra years of service when he retires in February -- a move...

• FDA Panel Backs Safety, Benefits of Spiriva

  19 Nov 2009 | 12:47 pm

  From Associated Press (November 19, 2009) WASHINGTON-Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims. The Food and Drug Administration's panel of...

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  WorldPharma News

• 85% of Online Europeans Use the Internet for Health Information

  19 Nov 2009 | 3:01 pm

  In 2009, 85% of online Europeans in the United Kingdom, Germany, France, Italy, and Spain turn to the Internet and other technologies for health and prescription drug information, according to the latest Cybercitizen Health® Europe v9.0 study from healthcare and pharmaceutical market research company Manhattan Research. The collaboratively-edited Wikipedia again proves to be a top online health resource for consumers in all of the countries surveyed.

• FDA Advisory Committee Finds Data Support SPIRIVA® HandiHaler®

  19 Nov 2009 | 3:00 pm

  The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).

• AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor)

  19 Nov 2009 | 1:23 am

  AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.

• GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction

  18 Nov 2009 | 3:00 pm

  GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) announcedan exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.

• Study Meets Primary Endpoint with 25 Percent LDL Reduction in Very High-Risk Patient Population

  17 Nov 2009 | 3:01 pm

  Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented at the American Heart Association's Scientific Sessions.

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  BNET Pharma

• Pfizer - Prempro: Kris Hundley writes

  PharmaGossip

  20 Nov 2009 | 6:00 am

  Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard? If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug's manufacturer nationwide could be released for the public to inspect.... Pharmalot - Secret Prempro Documents To Surface In Florida?

• Movetis plots European IPO

  FierceBiotech

  20 Nov 2009 | 5:30 am

  Belgian drugmaker Movetis said today that it will seek up to €112.4 ($167 million) in an upcoming IPO. The gastroenterology company--which was founded in 2006 as a spin-off Johnson & Johnson units Janssen and Ortho-McNeil--recently won European approval of its chronic constipation treatment... The In Vivo Blog - Financings of the Fortnight Has European Flavor, Roadshow Fever

• Julie Brill Nominated to FTC: A Message to Drug Manufacturers?

  The In Vivo Blog

  19 Nov 2009 | 10:38 am

  The Obama administration may have sent a subtle message to drug manufacturers Monday, when it nominated Julie Brill to be one of two new commissioners at the Federal Trade Commission. The message? Make sure your marketing practices don’t collide with consumers’ best interests.Brill has... Pharmalot - Pharma Watchdog Nominated As An FTC Commish

• Ruling could remodel whistleblower world

  FiercePharma

  19 Nov 2009 | 8:17 am

  A federal appeals court has ruled that Cell Therapeutics can pursue a claim for nearly $23 million against a former consultant that advised it to market a drug off-label, adding a whole new wrinkle to whistleblower lawsuits. Report More information about formatting options Pharmalot - Biotech Can Sue Consultant Over Whistleblower Loss

• Judge: Send federal Seroquel suits to courts

  FiercePharma

  19 Nov 2009 | 7:49 am

  While AstraZeneca preps for its first Seroquel liability trials at the state level, federal lawsuits are coming closer to court as well. U.S. District Judge Anne Conway, who's overseeing pretrial work for thousands of federal Seroquel cases, said she will ask a panel of judges to send all those... PharmaGossip - AstraZeneca - Seroquel: bring it on!

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  Pharmaceutical Manufacturing

• FDA Issues 22 Warning Letters to Web Site Operators

  Pharma Manufacturing

  19 Nov 2009 | 12:00 am

• Is A-Mab a Game Changer

  Pharma Manufacturing

  19 Nov 2009 | 12:00 am

  This QbD biologics case study has something (maybe too much) for everybody.

• Flexicon Corp.

  Pharma Manufacturing

  18 Nov 2009 | 12:00 am

  Box-Container Dumper Unveiled by Flexicon

• Market Intelligence Report: Tracking Your Workforce

  Pharma Manufacturing

  18 Nov 2009 | 12:00 am

  While many drug manufacturers are successfully tracking their workers in terms of attendance, skills, training, and habits, our recent survey shows there is much room for improvement. Most notably, there are still many manufacturers who are tracking workers on paper, or are not getting critical information that could be beneficial. This video-the first of a series of reports by PharmaManufacturing.com-provides an overview of our survey data and suggests how manufacturers can leverage workforce knowledge for operational improvement. A PDF of our final survey data is also available.

• Bovie Screen Process Printing

  Pharma Manufacturing

  18 Nov 2009 | 12:00 am

  Antimicrobial Coating for Overlays

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  MedWorm: Pharmaceuticals

• 19.11.09: Positive Results from Chronic Study with Bayer's Rivaroxaban Will be Presented As a Late Breaker at ASH 2009

  20 Nov 2009 | 6:01 am

  Positive Results from Chronic Study with Bayer's Rivaroxaban Will be Presented As a Late Breaker at ASH 2009Endpoints met in EINSTEIN-Extension Trial in the Secondary Prevention of Recurrent Symptomatic VTEmehr ... (Source: Bayer IR Newsfeed: Events)MedWorm Message: Get the very latest Swine Flu news via the MedWorm Swine Flu RSS news feed - updated hourly from thousands of authoritative health and news sources.

• DIA Safety Conference To Explore Solutions To Challenges Facing Pharmaocovigilance And Risk Management Strategies

  20 Nov 2009 | 6:01 am

  The Drug Information (DIA) will host its 9th Annual Conference on Contemporary Pharmacovigilance and Risk Management Strategies from January 10-13, 2010 in Washington, DC. (PRWeb Nov 19, 2009) Read the full story at http://www.prweb.com/releases/DIA/Safety_Conference/prweb3230364.htm (Source: PRWeb: Medical Pharmaceuticals)

• Nutra Pharma Introduces Chronic Pain Reliever, Nyloxin OTC, for International Distribution

  20 Nov 2009 | 6:01 am

  Nutra Pharma has introduced Nyloxin OTC, an over-the-counter pain reliever, that will be marketed and sold through international distribution channels alongside the Company's prescription pain reliever, Nyloxin Rx. (PRWeb Nov 19, 2009) Read the full story at http://www.prweb.com/releases/Nutra_Pharma/Nyloxin_OTC/prweb3231994.htm (Source: PRWeb: Medical Pharmaceuticals)

• ProMetic Life Sciences Inc.: SaBTO Recommends Use of P-Capt(R) Prion Reduction Filter to Protect Children From vCJD Blood Transmission

  20 Nov 2009 | 5:15 am

  MONTREAL, QUEBEC, CANADA and LILLE, FRANCE (MARKET WIRE) ProMetic Life Sciences Inc. (TSX: PLI) ("ProMetic") and MacoPharma SA ("MacoPharma") announce that the Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO"), an independent Committee that advises the UK Department of Health ("DoH"), has recommended the adoption of the P-Capt(R) prion reduction filter to pre-treat red blood cells destined for children born since 1 January 1996. The filter, which 'cleans' blood prior to use, removes the prion responsible for variant Creutzfeldt-Jakob disease ("vCJD"). The Committee also…

• GLG Life Tech Corporation: GLG Life Tech Corporation Commences Trading on NASDAQ

  20 Nov 2009 | 5:15 am

  VANCOUVER, BRITISH COLUMBIA (MARKET WIRE) GLG Life Tech Corporation (TSX: GLG)(NASDAQ: GLGL) ("GLG" or the "Company"), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has commenced trading on the NASDAQ Global Market under the symbol "GLGL". GLG's common shares are dual listed on the Toronto Stock Exchange and the NASDAQ Global Market. (Source: Market Wire - Pharmaceuticals and Biotech)

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  Topix: Pharma News

• But These Reagents, Where Are They?

  20 Nov 2009 | 10:53 am

  Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other ...

• Merck, Shopping in the UK?

  20 Nov 2009 | 6:22 am

  Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other ...

• Op-Eds: HIV Travel Ban; Improving Sanitation; Counterfeit Drugs

  20 Nov 2009 | 5:00 am

  Main Category: HIV / AIDS Also Included In: Water - Air Quality / Agriculture ; Pharma Industry / Biotech Industry Article Date: 20 Nov 2009 - 5:00 PST 'Blot' On U.S. HIV/AIDS Leadership Removed A "blot" on U.S. HIV/AIDS leadership "ended last month when President [Barack] Obama lifted the prohibition " that kept HIV-positive foreigners from ...

• Daschle Still Making Voice Heard On Health Care

  20 Nov 2009 | 5:00 am

  Main Category: Health Insurance / Medical Insurance Also Included In: Pharma Industry / Biotech Industry ; Pharmacy / Pharmacist ; Public Health Article Date: 20 Nov 2009 - 5:00 PST The Hill reports that former Senate Majority Leader Tom Daschle helped Obama Administration officials strategize to win health care reform votes from Senators on ...

• Lawmakers Call For Inquiry Into Pharmaceutical Company Price Hikes

  20 Nov 2009 | 5:00 am

  Main Category: Pharma Industry / Biotech Industry Also Included In: Health Insurance / Medical Insurance Article Date: 20 Nov 2009 - 5:00 PST Reuters : "Congressional Democrats are seeking government investigations into recent price increases of brand-name prescription drugs, as Congress finalizes an overhaul of the healthcare system.

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  InPharmaTechnologist

• Vaccine demand a friend to Pall in Q1; but sales still fall 5.4%

  19 Nov 2009 | 2:00 am

  Continued high demand for vaccine manufacturing technologies saw life sciences emerge as one of the few positives for industrial processing specialist Pall in Q1.

• UCB to cut 200 jobs in UK and Belgium

  19 Nov 2009 | 2:00 am

  Belgian biotech UCB is to reduce workforce 2 per cent as part of R&D restructuring plan according to various reports.

• People on the move: pharma jobs

  19 Nov 2009 | 2:00 am

  in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Xoma and Watson Pharmaceuticals, plus a new role for Fred Hasaan.

• Reimportation is “legislative madness”

  19 Nov 2009 | 2:00 am

  It is “legislative madness” to allow reimportation in the US, according to the chair of EAASM who spoke at AAPS about Europe’s “porous supply chain” and how it could affect the standard of medicines in the States.

• GBM trial to deliver Avastin across BBB

  18 Nov 2009 | 2:00 am

  Neurosurgeons have developed and used a novel intra-arterial (IA) technique to deliver Avastin (bevacizumab) directly into a malignant brain tumour, potentially administering a higher dose with reduced toxicity.

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  Pharma Marketing Blog

• Is Google the New FDA?

  19 Nov 2009 | 5:15 am

  At the recent FDA public hearing, Google presented its "ideas" for standard paid search ads for Rx products. The following, for example, shows its "proposal" for "Black Box Sponsored Links:"According to Klick Pharma's "Applying FDA Regulations to Online Marketing" guide, "Products with boxed warnings do not have the same flexibility in terms of creating reminder ads, as this form of ad is not permitted by the FDA for such drugs. While many boxed warning drugs have and continue to use branded reminder ads for search, it is not advisable given the current environment."Bayer has chosen not to…

• Women May Achieve 0.2 More "Satisfying Sexual Events" Per Week with BI's New "Desire Pill"!

  17 Nov 2009 | 5:51 am

  Stop the presses! I mean literally stop press coverage of a new drug under development by the family-owned drug company Boehringer Ingelheim GmbH (BI). A glowing Bloomberg story proclaims "Boehringer’s Desire Drug Boosts Lust, Improves Sex."I wonder if the Bloomberg reporter wrote this story with her tongue in her cheek or somewhere else. At least the BI Tweeter (@Boehringer) seemed pretty excited in this tweet sent out a few hours ago: "Great Bloomberg article on female sexual desire and recent medical research from Boehringer Ingelheim http://bit.ly/44CIt #ESSM" The #ESSM hash tag refers…

• FDA Social Media Guidelines Best Done in Baby Steps

  14 Nov 2009 | 6:42 am

  In his closing remarks at yesterday's public hearing on FDA regulation of social media, Tom Abrams, Director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), said "what we have heard is it's a different medium."As far as I know, this is the first time that anyone at the FDA has said that. Usually, the FDA says it's "media-agnostic." In other words, its regulations apply to all media and do not have to be modified for any particular medium.I suspect that was just a defense for why the agency has not provided any specific guidelines for use of the Internet.In fact,…

• FDA Social Media Hearing Day 1: My Key Takeaways

  13 Nov 2009 | 4:10 am

  In my presentation before the FDA at yesterday's public hearing, I made some specific suggestions, including the use of an FDA-designated hash tag to be included in each branded Tweet posted by pharmaceutical companies. If each product was assigned a unique hash tag by the FDA and all product tweets were required to include that hash tag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation.After my presentation, Tom Abrams, director of FDA's Division of Drug Marketing,…

• I'm Off to FDA Hearing: Here's What I Plan to Show (PPTs) and Tell (Transcripts)

  11 Nov 2009 | 7:58 am

  I am scheduled to make two presentations at the November 12 - 13 FDA public hearing on the use of social media for Rx (and device) promotion:Presentation #1: Accountability, Fulfilling Regulatory Requirements, and Posting Corrective InformationDate: November 12, 2009Time: 9:30 - 9:45 AMPowerpoint Deck: http://www.virsci.com/JMack-FDASM-Slides_Part1.pdfTranscript: http://www.virsci.com/JMack-fdaSM-Presentation1transcript.pdfPresentation #2: Social Media and Adverse Event ReportingDate: November 13, 2009Time: 10:20 - 10:30 AMPowerpoint Deck:…

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  BioSpace.com

• Carvedilol Shown To Have Unique Characteristics Among Beta Blockers, University of Illinois Study

  20 Nov 2009 | 4:00 am

  var addthis_pub"bdwyer";

• New Information Technology Fails To Accelerate FDA Drug Approvals, Reports

  20 Nov 2009 | 4:00 am

  var addthis_pub"bdwyer";

• Procter & Gamble Repurchasing Shares, Quiet on Potential Deals

  20 Nov 2009 | 4:00 am

  var addthis_pub"bdwyer";

• Xigen S.A., Swiss Developer of Therapeutic Peptides, Raises $20 Million in Series B Funding

  20 Nov 2009 | 4:00 am

  var addthis_pub"bdwyer";

• Antigenics Inc. (New York) Cancer Vaccine Gets Negative EU Panel Vote

  20 Nov 2009 | 4:00 am

  var addthis_pub"bdwyer";

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  PharmaLittle

• NYT TO PHARMA--FUGGEDABOUDIT

  18 Nov 2009 | 5:35 am

  Reform for Raising PricesFollowing its earlier report about record-breaking increases on drug prices, the NYT today editorializes that Congress should abandon its "deal" with the drug industry, which traded industry support for healthcare reform for $80 B in price cuts, mainly to Medicare and Medicaid.http://www.nytimes.com/2009/11/18/opinion/18wed3.html?emc=tnt&tntemail1=yThe industry claims are all those we've heard in every other context in which its interest has needed defending--the price of new drug development, meeting FDA's regulatory demands, etc., etc.. How real was this "deal"…

• DEVICE LOBBY TO HOUSE--SUSTAIN PREEMPTION!

  12 Nov 2009 | 6:36 pm

  In a statement released by Advamed, the medical device folks appear to be endorsing significant provisions of health-care reform as passed by the U.S. House. But they go out of their way to warn about compromising FDA preemption, framed in the code language of allowing states to create a variety of standards.See the statement here:http://presszoom.com/story_150419.htmlAs others have observed, it appears that the language of "tort reform" and "preemption" will be at the core of arguments used by those who would like to "bend the curve" of reform toward their particular interests.

• Swine flu Vaccine - I think I'll.... nope not for me....

  4 Nov 2009 | 5:33 am

  About the swine flu pandemic..I am sorry for people who get sick with the flu, I am deeply sorry for anyone who becomes gravely ill and for those families who have lost a loved one.At this point in time though, I am in morning over the missed opportunity we had to yet once again, teach our fellow human beings how to stay healthy. We've been extolled to wash our hands, get the vaccine. It goes much deeper than that. We should be sending flyers to homes about eating healthy, getting out in the fresh air, exercising....No, instead we are opting for the "quick fix solution" - which really isn't a…

• 600 Suits Against Medtronic Dismissed

  27 Oct 2009 | 6:02 pm

  The (Preemption) Beat Goes On.....FDA preemption in the arena of devices still rules in many cases. Here is a report about a judge in Minnesota who dismissed 600 cases against Medtronic over the Sprint Fidelis pacemaker.http://massdevice.com/news/minnesota-judge-dismisses-600-sprint-fidelis-suits-against-medtronicAs most here will know, there is a bill in Congress now that would amend the Medical Device Act in order to allow tort liability for FDA-approved medical devices.It is also well known that "irregularities" in FDA's device approval process increasingly make the news. As we report…

• THE NEW PHARMALITTLE

  18 Oct 2009 | 10:40 pm

  It's Not Good-bye. It's Onward!Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of…

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  Drugs.com: FDA Med Watch Alerts

• Vicks Sinex Nasal Spray - Recall

  18 Nov 2009 | 9:00 pm

  Audience: Consumers Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of...

• RockHard Weekend - product contains undeclared drug ingredient

  17 Nov 2009 | 9:00 pm

  Audience: Consumers, pharmacists RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as...

• Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

  16 Nov 2009 | 9:00 pm

  Audience: Cardiovascular healthcare professionals, pharmacists FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec...

• IDS Sports Dietary Supplements - Recall

  16 Nov 2009 | 9:00 pm

  Audience: Consumers IDS Sports and FDA notified consumers that five of the IDS's dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA...

• Pai You Guo, Marketed as Dietary Supplement - Recall

  12 Nov 2009 | 9:00 pm

  Audience: Consumers GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary...

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  Drugs.com - New Drug Approvals

• NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

  16 Nov 2009 | 3:21 pm

  SAN MATEO, Calif., Nov. 16 /PRNewswire-FirstCall/ -- NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza (capsaicin) 8% patch, the first and only product containing prescription strength...

• Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding

  16 Nov 2009 | 5:43 am

  NEWPORT, Ky., Nov. 16 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that...

• FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

  13 Nov 2009 | 4:01 am

  ROCKVILLE, Md., Nov. 12, 2009--The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults,...

• FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients

  6 Nov 2009 | 7:46 am

  PRINCETON, N.J.--(BUSINESS WIRE)--Nov 5, 2009 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Reyataz to include long-term data from the CASTLE Study. The CASTLE...

• FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma

  6 Nov 2009 | 7:46 am

  CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 5, 2009 - Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have...

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  Drugs.com - New Drug Applications

• AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

  19 Nov 2009 | 5:40 am

  WILMINGTON, Del., Nov. 19 /PRNewswire-FirstCall/ -- AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the...

• NicOx announces FDA accepts naproxcinod NDA for filing

  18 Nov 2009 | 5:40 am

  Sophia Antipolis, France, November 18, 2009-NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for...

• Genzyme Receives Complete Response Letter on Lumizyme Application

  17 Nov 2009 | 12:15 pm

  CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 16, 2009 - Genzyme Corporation announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe...

• Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets

  16 Nov 2009 | 12:00 pm

  CAMBRIDGE, Mass. & VANCOUVER--(BUSINESS WIRE)--Nov 16, 2009 - CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed...

• Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application

  16 Nov 2009 | 11:55 am

  ROCKVILLE, Md.--(BUSINESS WIRE)--Nov 16, 2009 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company's Biologics...

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  Drugs.com - Clinical Trials

• Ligand Presents New Preclinical Data on its Lead SARM Molecule LGD-4033 at the Gerontological Society of America Annual Meeting

  20 Nov 2009 | 5:11 am

  SAN DIEGO--(BUSINESS WIRE)--Nov 20, 2009 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at...

• Inovio Biomedical Universal Flu Vaccines Demonstrate Broadly Protective Immune Responses Against Multiple Seasonal & Pandemic Influenza Viruses in Pre-Clinical Studies

  20 Nov 2009 | 4:53 am

  Inovio's SynConTM Universal Flu Vaccines Provide 100% Protection in Ferrets against Death and Sickness in a Challenge Study with the Pandemic H1N1 Virus SAN DIEGO--(BUSINESS WIRE)--Nov 20, 2009 - Inovio Biomedical Corporation (NYSE Amex:INO), a...

• Military Study Shows Prevention of Novel A/H1N1 Virus Infection is Vaccine-Type and Age-Dependent

  19 Nov 2009 | 11:58 am

  Both Live, Attenuated Influenza Vaccine (LAIV) and Trivalent Inactivated Vaccine (TIV) provide Protection against novel A/H1N1, especially against severe disease WASHINGTON, Nov. 19 /PRNewswire/ -- Immunization with either live attenuated influenza...

• Positive Results from Chronic Study with Bayer ?s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009

  19 Nov 2009 | 11:10 am

  Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009 Endpoints met in EINSTEIN-Extension Trial in the Secondary Prevention of Recurrent Symptomatic VTE Berlin, November 19, 2009 -...

• VIVUS Announces Positive Results From Phase 3 Study of Avanafil in Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile

  19 Nov 2009 | 5:56 am

  Results Underscore Differentiating Profile; Indicate Significant Market Opportunity for Avanafil MOUNTAIN VIEW, Calif., Nov. 18 /PRNewswire-FirstCall/ -- VIVUS, Inc. (NASDAQ:VVUS) today announced positive results from REVIVE (TA-301), a phase 3...

• 
  Pharmainfo.net

• Pfizer's Geodon gets expanded FDA approval

  20 Nov 2009 | 12:05 pm

  Pfizer's Geodon gets expanded FDA approval read more

• Heritage Provider Network CEO Dr. Richard Merkin, Announces the Acquisition of Lakeside Medical Systems, Inc.

  20 Nov 2009 | 11:23 am

  MARINA DEL REY, Calif., Nov. 20 /PRNewswire/ -- Heritage Provider Network, and its founder, CEO and President Dr. Richard Merkin, announce that as of November 6, 2009, Lakeside Medical Systems, Inc., as well as all its affiliated entities, have been acquired by Lakeside Medical Organization, part of the HPN family.

• Exxon Mobil, Bristol-Myers Squibb: Money Flow Leaders (XOM, BMY)

  20 Nov 2009 | 11:05 am

  Exxon Mobil, Bristol-Myers Squibb: Money Flow Leaders (XOM, BMY) Wall Street Journal - 1 hour ago Exxon Mobil Corp. topped the list at midday on Friday for Buying on Weakness , which tracks stocks that fell in price but had the largest inflow of money. See the full list . Bristol-Myers Squibb ...

• Bristol-Myers Squibb Looking Higher

  20 Nov 2009 | 11:05 am

  Bristol-Myers Squibb Looking Higher Trading Markets - 6 minutes ago Earlier this week, Bristol-Myers Squibb emerged to the upside from a two-year base-like accumulation pattern when the price structure hurdled and sustained above 23.80-24.00. Since then (Mon ...

• Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults

  20 Nov 2009 | 11:05 am

  Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults Reuters Key Development - 47 minutes ago

• 
  JNJ BTW

• How to Prevent the Spread of Swine Flu in Schools

  Guest

  18 Nov 2009 | 7:05 am

  From Bill Lin, Director, Corporate Contributions With the majority of swine flu cases occurring in children and young adults, schools have become a battleground for the disease. School nurses and administrators play a crucial role in preventing the spread of the swine flu and responding appropriately to outbreaks of flu cases in their schools and districts so healthy kids can continue going to school. The New Jersey Principals and Supervisors Association and Johnson & Johnson recently held a Swine Flu (H1N1) Preparedness Training Seminar to provide school health professionals and…

• A Leader’s Perspective on Ethics

  Guest

  13 Nov 2009 | 10:23 am

  From Devon Prutzman, Director, WW Communications, Ortho-Clinical Diagnostics Business ethics isn’t a new topic, but it does seem to take on particular relevance in light of today’s complex business environment. The tough challenges facing leaders in all sectors of society certainly aren’t going to be solved overnight and one Johnson & Johnson leader recently recognized the importance of helping current and future business leaders better understand the role of ethics in shaping the way they — and their organizations — do business. I had the chance to watch Ortho-Clinical…

• Greetings From the FDA Hearings on Social Media

  Marc

  13 Nov 2009 | 8:31 am

  As I’ve mentioned before on this blog, though healthcare companies (like Johnson & Johnson) would like to take a more active role in the ongoing conversations online, most are still sitting on the sidelines. Why? Well, there are a number of reasons, but one of the biggest is that there is quite a bit of uncertainty about just what is appropriate under the current regulatory framework. It’s all rather complicated, but in the US a lot of the uncertainty around how to engage online concerns how companies that sell highly regulated prescription medications and medical devices can do so…

• Diabetes “Role” Call: Animas? Here!

  Chris Campbell

  29 Oct 2009 | 9:08 am

  “What is our role in social media within the Diabetes Community and who gets to define it?”  All companies are trying to cross the bridge from the conventional way we’ve always communicated with customers to participating in the social communities where our customers are talking to one another.  It is a scenario filled with all the adolescent angst of trying to insert yourself into a conversation between the “cool” kids in school whom you are afraid will reject you if you say the wrong thing.  The truth is that every company is struggling with the same…

• How Can You Prevent Breast Cancer?

  Guest

  28 Oct 2009 | 5:35 am

  From Kristin Cooke, Breast Care Specialist, Ethicon Endo-Surgery October marks the beginning of many things each year: the falling of leaves, the first frost, Halloween and Breast Cancer Awareness Month. You may have noticed the pink ribbons, gloves and hats worn by the players, coaches and refs of the NFL. You have probably seen billboards around your city advertising in pink. And if you have been anywhere near your local hospital, it is likely there are pink ribbons tied around trees or hanging from a banner atop the hospital. Many of you may be thinking, why all of the hoopla? Well, here…

• 
  Merck.com - Product News

• Higher Dose of Merck's COZAAR� (losartan potassium tablets) Significantly Reduced Deaths and Hospitalizations Due to Heart Failure In Investigational Study

  16 Nov 2009 | 4:00 pm

• Merck Expresses Confidence in the Efficacy and Safety Profiles of ZETIA� (ezetimibe) and VYTORIN� (ezetimibe/simvastatin) as Effective Medicines for Managing Elevated Cholesterol

  20 Oct 2009 | 5:00 pm

• CDC Advisory Committee on Immunization Practices Votes for Permissive Use and for Vaccines for Children Funding for GARDASIL� for Boys and Young Men

  20 Oct 2009 | 5:00 pm

• 
  Google News: Pfizer

• Pfizer's Geodon gets expanded FDA approval - The Associated Press

  20 Nov 2009 | 11:38 am

  Pfizer's Geodon gets expanded FDA approvalThe Associated PressNEW YORK — Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part of a combination maintenance treatment for bipolar disorder in Pfizer Receives FDA Approval For Geodon® (Ziprasidone HCI) Capsules For The WELT ONLINEPfizer Announced FDA Approved Geodon For Bipolar Disorder (PFE)Comtex SmartrendPfizer Announced FDA Approved Geodon For Bipolar Disorder (PFE)Trading Markets (press release)MSN Money -DG Newsall 137 news articles »

• Pfizer gets FDA approval for intravenous Revatio - The Associated Press

  20 Nov 2009 | 8:36 am

  Pfizer gets FDA approval for intravenous RevatioThe Associated PressNEW YORK — Drug developer Pfizer Inc. said Friday the Food and Drug Administration approved an intravenous version of its high blood pressure drug Revatio. Pfizer Granted FDA Approval For Intravenous Formulation Of Revatio - UpdateRTT NewsFDA Approves Intravenous Formulation Of Pfizer's Revatio® (Sildenafil) For The WELT ONLINEFDA approves injection formula of RevatioDrug Store News (blog)all 68 news articles »

• Antitrust Lawyer Files Suit to Stop Pfizer Merger - PharmaLive.com (press release)

  20 Nov 2009 | 7:47 am

  Antitrust Lawyer Files Suit to Stop Pfizer MergerPharmaLive.com (press release)20--A prominent San Francisco antitrust attorney said Thursday he has filed a request in federal court for a temporary restraining order against Pfizer Inc. and more »

• Pfizer Executive:In Talks To Expand Licensing Pact With Aurobindo - Wall Street Journal

  20 Nov 2009 | 6:04 am

  Pfizer Executive:In Talks To Expand Licensing Pact With AurobindoWall Street JournalWe are starting to get into the stage of negotiating future developments (with Aurobindo Pharma)," David Simmons, general manager of Pfizer's established Pfizer's Generics Business Takes ShapeWall Street Journal (blog)Goldman: China's No. 1 pharma will be PfizerFiercePharmaAurobindo Pharma aims to treble revenue by 2014Livemintall 7 news articles »

• Pfizer Says FDA Advisory Committee Supports SNDA For SPIRIVA HandiHaler ... - RTT News

  19 Nov 2009 | 2:07 pm

  Pfizer Says FDA Advisory Committee Supports SNDA For SPIRIVA HandiHaler RTT News(RTTNews) - Pfizer Inc. (PFE: News ) said Thursday that the US Food and Drug Administration or FDA Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 UPDATE 1-US panel backs new claim for Pfizer lung drugReutersFDA panel backs safety, benefits of SpirivaThe Associated PressUS panel backs new claim for Pfizer lung drugForbesTrading Markets (press release) -Genetic Engineering News (press release)all 187 news articles »

• 
  Pharm Blog Review

• J&J job cuts kick off week

  Chris

  6 Nov 2009 | 1:35 pm

  It’s a mixed bag this week in pharma industry news (much like that sack of your kids hauled home from their trick-or-treating, for every KitKat, there’s a bag of candy corn). Some of the notable items: Johnson & Johnson announced the company would be reducing its headcount by 7% (and Eli Lilly also announced some layoffs in Indiana); now that Merck & Co. is the No. 2 drugmaker, the company is poised for future buys (but FDA would not accept Merck’s application for a combination cholesterol pill); GlaxoSmithKline and Pfizer launched their joint HIV venture, ViiV…

• For Halloween, some bloggy treats (no tricks)

  Chris

  30 Oct 2009 | 1:04 pm

  Halloween is tomorrow, but for the pharmaceutical industry, the real “party” will be November’s two-day meeting on social media use, sponsored by FDA. Everyone is hoping the hearing will yield a treat (in the form of a workable guidance on social media) and not tricks (in the form of FDA remaining inscrutable and issuing warning letters). This week was yet another conference, ePatient Connections in Philadelphia sponsored by Kru Research; although the main focus was communicating with empowered patients, there was another discussion about the pharma industry’s use of…

• Pharma still uneasy about getting social

  Chris

  23 Oct 2009 | 12:51 pm

  This week was full and frantically busy, and I am not just talking about the three days I drove back and forth to Bridgewater, N.J., for ExL Pharma’s Digital Pharma conference (if you want the quick lowdown on what happened there, you can find the Tweets, from me and many others, under the hashtag #DigPharm). This week, AstraZeneca offered a buyout to all of its sales representatives (and Pharmalot broke the news); Pfizer started handing out layoffs to most of the former Wyeth sales force; FDA sent a warning letter to King Pharmaceuticals over two video news releases about the pain drug…

• Pfizer pfuels burst of blogger speculation

  Chris

  16 Oct 2009 | 1:31 pm

  The week ended in a big way, as Pfizer’s acquisition of Wyeth became final and FDA approved GlaxoSmithKline’s Cervarix vaccine for cervical cancer. Also, debate continued about the healthcare reform bill passed by the Senate Finance Committee last week. And fortunately for the industry, no recent bombs about ghostwriting or other scandals hit the air. (The cynical side of me says just give it some time, though.) One big happy family Jacob Goldstein at the Wall Street Journal Health Blog gathered some news about which Pfizer and Wyeth sites would be staying open and which would be…

• Catching up, after vacation

  Chris

  9 Oct 2009 | 2:29 pm

  Now that I’m back in the office from my Boston vacation (and a very interesting visit last Monday with Jeff Porter, Tim Wright, and Mark Fishman of Novartis Institutes for Biomedical Research, which I will be writing about in January’s R&D Directions), I have some stuff to catch up on. Abbott is buying Solvay’s pharmaceutical business for $6.6 billion. Allergan is suing the government for restricting the company’s right to share clinical information about Botox for certain off-label therapeutic uses. IMS Health predicted 4% to 6% global pharmaceutical market growth…

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  Pharma Strategy Blog

• Buzzword bingo at AACR

  MaverickNY

  19 Nov 2009 | 7:05 pm

  After typing a short, but thoughtful, piece into the Typepad mobile app on the iPhone, it crashed into the cyber ether before I could send or save it.  Arrrgh! It's always difficult restarting and retracing steps from scratch because the whole point of the mobile app is that it allows you to capture those sudden brainwaves and quick thoughts so easily.  Maybe next time I'll stick to audio and posting it via Posterous instead.  This made me realise that what we really need is a service that does a transcript of audio for say, a report or blog post, and allows editing before…

• links for 2009-11-18

  MaverickNY

  18 Nov 2009 | 4:03 pm

  Finding Breast Cancer Early: Age 40, Every Year We do believe that we should aim to choose 100% of the benefit. We should not forget that the “benefit” in this situation is reducing deaths from breast cancer. A 30% reduction in saving lives is not acceptable. We also recognize that mammograms are not perfect. We realize that women do have to get additional studies for suspicious lesions. We realize that some women have biopsies that do not show breast cancer. We realize that our predictive tests are not perfect, so that we can’t say with certainty which breast cancers are aggressive and…

• What's new at AACR on molecular targeting and biomarkers?

  MaverickNY

  18 Nov 2009 | 8:13 am

  At the AACR molecular targeting meeting in Boston, several key presentations have focused on lessons learned from previous kinase studies and using them to help guide future developments. Charles Sawyers from MSKCC put together a particularly nice presentation looking at the lessons learned from CML and prostate cancer.  He noted that 75% of CML patients respond to imatinib and attain a complete cytogenetic response, with only a small number, 20% relapsing by 5 years. The question is why and what can be done to change this?  Firstly, the natural course of the disease predicates that…

• The increasing use of social media to recruit patients for clinical trials

  MaverickNY

  17 Nov 2009 | 4:54 am

  In an effort to speed up the time to market, companies have always wanted to recruit clinical trials faster.  Traditional media was the starting point e.g. sending trial information to advocacy groups, advertising on television, radio, posters, bill-boards etc.  Now companies are increasingly looking at how social media can channel patients into clinical trials.  This is an exciting area that is outside of the reach of the current FDA debate on how social media is used for drug promotion.Various models are now slowly emerging:1.  Communities of people with similar diseasesClinical trial…

• Does the clinical benefit of a drug justify it's cost?

  MaverickNY

  16 Nov 2009 | 4:57 am

  The Obama administration provided $1.1 billion for health care comparative effectiveness research in the American Recovery and Reinvestment Act (ARRA).  Following this, the Institute of Medicine (IOM) delivered a report in June with comparative effectiveness research priorities (downloadable file).  However, it remains to be seen how comparative effectiveness will work in the U.S. to control costs and guide payers and providers on the cost/benefit of treatment options.  There is little being said about comparative effectiveness in the debate on health care reform, which seems to be driven…

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  Pharma's Cutting Edge

• The end of PCE?

  In case you are one of the folks who subscribe to my RSS feed or just found the site and were wondering why there have been no posts since April, this note's for you. Here's the truth.  I enjoy writing the occasional editorial on our industry, and I especially enjoy it ...

• Provenge success definitive now it seems

  I last wrote about Dendreon's Provenge active immunotherapy for prostate cancer back in May of 2007, when I raised questions about FDA's decision not to approve the therapy, despite a favorable advisory committee opinion. Today, I am happy to pass along news of positive top-line results from a confirmatory Phase 3 ...

• A case study of publication bias

  Have a look at a recent paper by an osteopath with strong anti-industry sentiment who nevertheless manages to put together a study that systematically (and mostly fairly) examines the biases evident among published reviews of rimonabant. I say "mostly fairly", because I found the editorializing to be all over the place, an anti-industry ...

• 
  PharmaGossip

• AstraZeneca - Seroquel: it must all have been a dream!

  20 Nov 2009 | 8:27 am

  Story! LOL

• Pfizer - Prempro: Kris Hundley writes

  20 Nov 2009 | 6:00 am

  Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard?If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug's manufacturer nationwide could be released for the public to inspect.The key to the confidential company records has ended up in Pinellas-Pasco Circuit Judge Anthony Rondolino's hands because of a clerical misstep and a unique Florida statute.A hearing on the matter is scheduled for Monday, though attorneys were negotiating a possible resolution late Thursday.More than…

• Ghostwriting 101

  20 Nov 2009 | 4:11 am

• Henri, I'm sure you are worth every cent!

  20 Nov 2009 | 3:08 am

  Jim has the story!

• How to report a possible medicine related adverse event to the FDA

  20 Nov 2009 | 12:37 am

  1. Click on this link:https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm2. Click on "BEGIN" - it's on the right of the pageClick the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of: FDA-regulated drugs,biologics (including human cells, tissues, and cellular and tissue-based products)medical devices (including in vitro diagnostics)special nutritional products and cosmetics 3. Answer the questions as they appear

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  Pharma 2.0

• FDA hearings on social media in progress

  Bunny Ellerin

  12 Nov 2009 | 8:20 am

  The day has arrived – the big FDA hearings on social media. People are tweeting and blogging and texting and posting every single word of the testimony. It is surreal and exhausting to follow, which I only do sporadically. There will so many post-mortems on the two days I can wait to pick and choose. But should you wish to partake http://www.fdasm.com: private (not affiliated with FDA) site nicely done site by Fabio Gratton of Ignite Health FDA speakers – those chosen by FDA to speak at the meeting Twitter: #fdasm As an aside, I often wonder how many of the self-made social media…

• Social pharma

  Bunny Ellerin

  5 Nov 2009 | 10:55 am

  Activity is heating up in the social pharma arena just as the FDA meeting approaches next week. A few concrete examples of progress on the engagement front. Lilly used Twitter to promote its Oncology on Canvascompetition, now in its fifth year. Lilly launched this “Expressions of a Cancer Journey Art Competition and Exhibition” in 2004 to acknowledge those affected by cancer, including patients, caregivers, friends and family members. The artwork from last year’s contest is on the site – really quite lovely. Boehringer Ingelheim teamed up with our friends at the…

• FDA to take up social media

  Bunny Ellerin

  21 Sep 2009 | 2:31 pm

  Save the Date! November 12th and 13th in Washington DC, you are cordially invited to attend the FDA’s first ever public hearing on “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” This is excellent news that many in our industry should welcome. Will anything substantive get done? Always unclear. I have been to these kinds of meetings before and there is much talking and commenting, which is not always followed by action on the part of the Agency. That said, the fact that FDA is finally holding a public forum on…

• Patients connecting on CML Earth from Novartis Oncology

  Bunny Ellerin

  18 Aug 2009 | 5:22 am

  Tearing myself away from Twitter for a few minutes to share info about an example of pharma engagement: check out CML Earth a global social network for those affected by chronic myeloid leukemia. The site was developed and is supported by Novartis Oncology to help connect patients, patient advocacy groups and healthcare professionals touched by this rare cancer. For some reason it has not gotten as much coverage as other (albeit few) social media initiatives from pharma even though it was launched in late December (08). CML Earth allows members to create profiles where they can describe their…

• The C-Tweet: Where are all the healthcare CEO’s?

  Bunny Ellerin

  30 Jul 2009 | 9:21 am

  This article was co-written by Bunny Ellerin of Pharma 2.0 and Eileen O’Brien, digital pharma diva. Tweeting is fast becoming a must-do vs. a what-are-you-doing for business generally and CEO’s in particular. Just last week Twitter published Twitter 101, a guide to help businesses leverage the service. Last month, BusinessWeek ran an article about business leaders who use Twitter and profiled 50 CEO’s from a range of industries. There was definitely an over-representation of tech CEO’s, but BW also talked to those from advertising/pr, construction, research, media, retail. But…

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  BeyeNETWORK Biopharma Channel

• Impax Laboratories Selects IBM Business Analytics

  20 Nov 2009 | 10:00 am

  Impax Laboratories, Inc. is using IBM business analytics technology to gain stronger insights into their business and better predict risks and market opportunities.

• Trends in the Healthcare Business Intelligence Marketplace

  16 Nov 2009 | 4:00 am

  Jason Oliveira looks at the trends in health information technology, emphasizing that exploiting the wealth data remains a formidable challenge for today’s healthcare organizations.

• Birst Announces Comprehensive Cloud BI Suite – Birst 4

  3 Nov 2009 | 10:00 am

  Software-as-a-service (SaaS) business intelligence (BI) solution enbables pervasive BI at any organization.

• Klipfolio Emphasizes KPI Visibility as Key to Daily Performance Decisions

  3 Nov 2009 | 6:00 am

  Exclusive interview featuring Klipfolio’s Allan Wille

• Klipfolio Prioritizes KPI Visibility for Daily Performance Decisions

  3 Nov 2009 | 6:00 am

  Exclusive interview featuring Klipfolio’s Allan Wille

• 
  S&R Blog

• The pharmaceutical industry is about to experience the biggest shift in product marketing history. Are you prepared?

  srcomblog

  19 Nov 2009 | 7:13 am

  Be prepared. Visit the site. View the videos. Know the issues. Read the write-up in Med Ad News.

• FDA social media (#FDASM) week kicks into high gear today

  srcomblog

  12 Nov 2009 | 7:18 am

  Starting today, the FDA will be holding a 2-day hearing on how pharmaceutical companies use the web and social-media tools to market their products. Sixty-two speakers from pharmaceutical companies, media companies, agencies, and others have been asked to give their viewpoints. Is it a little too late? Maybe. Is it a step in the right direction? Probably. Will the FDA, pharma and marketers have a better understanding on what needs to be done to regulate the internet and social media? Likely. Whatever the outcome, it’s about time. Follow all of the action (via real-time tweets) at…

• It’s raining pumpkins in Durham

  srcomblog

  11 Nov 2009 | 6:56 am

  After nearly 2 weeks of feasting on Halloween candy, we still have few post-halloween treats to share with everyone.

• 300 reasons CME is evolving

  srcomblog

  2 Nov 2009 | 8:32 am

  My, how far CME has come in the age of technology! It seems like just yesterday that CME was in the infancy stage of being offered through websites and portals. But now with the advent of ReachMD and its unique XM Radio/iPhone/social media approach to CME, physicians truly have a wide range of mediums to increase their knowledge. And it doesn’t stop there. According to the Bernard Sklar’s CME List their are more than 300 CME sites/portals/apps/podcasting available through the internet today compared to 87 just 10 years ago. And when you look at the physician participants from that…

• 78 percent of US interested in mobile healthcare solutions

  srcomblog

  19 Oct 2009 | 8:57 am

  Attention healthcare industry! Mobile healthcare solutions will be a reality sooner than you think. And we aren’t talking about just blood pressure monitoring apps, but full-blown health services. According to a new study conducted by wireless industry association CTIA with Harris Interactive, a vast majority of the US (78%) is interested in mobile health solutions and 15 percent of the U.S. is extremely or very interested in learning more about mHealth. The study used a combination of two online studies of U.S. adults (5,563) and physicians (115 general practitioners and 129 specialists)…

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  Dose of Digital

• Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had

  Jonathan Richman

  17 Nov 2009 | 9:59 pm

  It’s almost been almost a week since the FDA hearings on social media wrapped up. If you missed it, then you missed a bit of history. Well, you sort of missed a bit of history. It’s not the fall of the Berlin Wall or anything, but it’s pretty rare that the FDA has a hearing like this. I’m not going to begin to try to give you all the links you need to review what happened and instead I’m going to point you to the source for the latest and greatest on all things FDA social media, the #FDASM site created by Fabio Gratton. That’s where you can get links to all…

• November Pharma and Healthcare Social Media Wiki Updates

  Jonathan Richman

  11 Nov 2009 | 1:19 pm

  In honor of tomorrow’s FDA social media hearings, I thought it would be a great time to update the Pharma and Healthcare Social Media Wiki. While many companies remain on the sidelines of social media, others are passing them by. The wiki has hundreds of examples of pharma and healthcare companies using social media TODAY. No hearing required. No special permission. No guidelines. So, study up before the hearing and see what people are doing now. One thing to keep in mind for all the conservative regulatory and legal folks out there: not a single program on this wiki (now over 250…

• 166 Reportable Adverse Events Equals One Red Herring

  Jonathan Richman

  10 Nov 2009 | 7:53 am

  With just a few days until the long awaited FDA hearings on pharma’s use of social media, the buzz in our little community has certainly picked up. Heck, there’s even a site to track it all courtesy of Fabio Gratton. If you want the latest about these hearings, this site is a pretty good place to start. You can get a bunch of logistics information, see the Twitter buzz, and even download the presentations of those people who have made them available (you can get mine here). It’s all great. We’re finally going to have some guidelines around social media, which we all…

• A Sneak Preview of My FDA Social Media Hearing Testimony

  Jonathan Richman

  5 Nov 2009 | 7:20 am

  It’s almost that time. One more week until the FDA hearings that everyone has demanding for more than a year. As a refresher, on November 12-13, the FDA is holding a public hearing on the use of social media by pharma and medical device companies (and others). Officially, the title of the hearing is: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001). I recently posted the agenda for the meeting, but it has been updated. You can download the new agenda here: Updated Agenda for FDA Social…

• FDA Public Hearing on Social Media Agenda and Speaker List Released

  Jonathan Richman

  30 Oct 2009 | 5:05 am

  As most of you know, in a couple of weeks (November 12-13), the FDA is holding a public hearing on the use of social media by pharma and medical device companies (and others). Officially, the title of the hearing is: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001). Catchy, right? In any event, since this is a public hearing, people were allowed to request both a seat to attend the meeting and also to speak at the meeting. If you haven’t already applied for a spot, forget it, as the deadline…

• 
  BioPharma Today

• Coming in Monday's "The Pink Sheet" DAILY

  Wendy Diller

  20 Nov 2009 | 10:52 am

  Antigenics - Movetis- Actelion

• PBM Power Behind Pharmacogenomics: CVS Caremark Launching Program

  Sean

  20 Nov 2009 | 7:38 am

  CVS Caremark is expanding its commitment to pharmacogenomics with a new clinical and testing services program being developed in collaboration with newly-formed Generation Health, which describes itself as a genetic benefits management company. Announced Nov. 10, the program initially is expected to focus on predicting how patients respond to about a dozen drugs in therapeutic areas including oncology, cardiovascular disease and HIV treatment. Read on.....

• Latest News from "The Pink Sheet" DAILY

  Wendy Diller

  20 Nov 2009 | 6:48 am

  BI's Spiriva Gets Advisory Panel Nod For COPD Exacerbations Despite Statistical Issues - Saturday Night Special For Health Reform: Can Senate Coalition Hold? - M&A In India May Lose Steam As Potential Sellers Raise Prices, Investment Bankers Say

• Editors' Picks From Around the World

  Wendy Diller

  20 Nov 2009 | 6:35 am

  Doctors use embryonic stem cells to grow skin on mice - AstraZeneca submits Brilinta for FDA approval - Advanced Cell Technology seeks FDA clearance for stem cell trial

• Coming in Friday's "The Pink Sheet" DAILY

  Wendy Diller

  19 Nov 2009 | 10:46 am

  Spiriva safety issues may be key in advisory committee review of expanded COPD claim.

• 
  TradePub: Pharmaceuticals

• Pharm Rep Direct

  16 Nov 2009 | 11:20 am

  It covers new developments and cutting-edge advice from the world of sales management and training, as well as regulatory updates, must-know court cases, key statistics, exclusive interviews - you can find everything you need here, in Pharm Rep Direct.Request Free!

• PharmaVOICE

  13 Nov 2009 | 5:20 pm

  PharmaVOICE provides multiple perspectives on the business challenges, trends, and topics impacting the life-sciences by engaging compelling personalities from diverse industry sectors in a thought-provoking dialog to facilitate and improve business-to-business relationships. Your subscription to PharmaVOICE will also include it's supporting sector-specific VIEW publications.Request Free!

• American Biotechnology Laboratory

  13 Nov 2009 | 3:20 pm

  American Biotechnology Laboratory will help keep you abreast of the latest developments in life science instrumentation and apparatus, bioanalytical chemistry, kits, and biologicals.Request Free!

• American Laboratory

  13 Nov 2009 | 3:20 pm

  American Laboratory is a practical resource for analytical chemistry laboratory solutions for chemists and life scientists with interest in the application of modern scientific instrumentation for the practice of analytical/bioanalytical chemistry, basic research, applied spectroscopy, petrochemicals, and material science.Request Free!

• Surgical Products

  12 Nov 2009 | 4:20 pm

  Each issue provides information about new products, technology solutions, and industry insights in the surgical/healthcare field. Surgical Products is published 10 times a year (monthly except bi-monthly in Jan/Feb and Nov/Dec) and is available in Print or Digital format.Request Free!

• 
  Pharma QbD

• Podcast: QbD Software: Optimize Processes . . . and Thrill Executives

  mvaccarello

  17 Nov 2009 | 2:07 pm

  Design of Experiments software is being perfected for chromatography, dissolution, and tablet manufacturing, and as QbD goes “mainstream,” even pharmaceutical executives are shopping around for good software like this, says Graham Shelver of S-Matrix Corp. Shelver cautions that many software vendors will jump on the QbD bandwagon with products that have not proven themselves in pharmaceutical environments. read more

• Antibody Development and Production Conference

  mvaccarello

  12 Nov 2009 | 12:03 pm

  Date: 03/03/2010 End: 03/05/2010 Timezone: March 3-5, 2010 • La Costa Resort and Spa • Carlsbad, CA read more

• Conference: Overcoming Challenges in Upstream & Downstream Processing for Protein Therapeutics

  mvaccarello

  12 Nov 2009 | 11:59 am

  Date: 03/03/2010 End: 03/05/2010 Timezone: March 3-5, 2010 • La Costa Resort and Spa • Carlsbad, CA read more

• Conference: Ensuring Successful Process & Method Transfers to Internal, External and International Sites

  mvaccarello

  12 Nov 2009 | 11:49 am

  Date: 03/01/2010 End: 03/02/2010 Timezone: IBC's 4th Annual Technology Transfer for Biopharmaceuticals is the industry's only event that delivers best practices for optimizing every phase of the transfer process. read more

• Applying Risk-Based Approaches & Implementing QbD to Comply with Regulatory Requirements & Achieve Better Process Understanding

  mvaccarello

  12 Nov 2009 | 11:45 am

  Date: 03/01/2010 End: 03/02/2010 Timezone: March 1-2, 2010 • La Costa Resort and Spa • Carlsbad, CA read more

• 
  Adpharm pharmaceutical advertising intelligence

• Canadian Digestive Health Foundation

  19 Nov 2009 | 2:15 pm

  The Canadian Journal Of Gastroenterology - November 20090 viewsNov 19, 2009

• Aflamil

  19 Nov 2009 | 9:39 am

  MedicRo - May 20090 viewsNov 19, 2009

• Prilosec - Full Swing

  18 Nov 2009 | 6:06 am

  Day 2, back to class this evening. Back in full swing. Day 4, second class this week. Call me twinkletoes. Day 7 party time! Another night out without heartburn. Brand name: Prilosec Generic name/category: Omeprazole, Proton pump inhibitors (PPI) Company: AstraZeneca Country/Market: USA, North America Indication(s)/use: dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome Target: Consumers (DTC) Tagline: What day are you on? Medium: Print ad Size/duration: single-page Publication/Aired: More - March 2007 To see all of this…

• BD - More choices

  18 Nov 2009 | 4:11 am

  The Journal of Immunology - September 20090 viewsNov 18, 2009

• Revlimid - Strond and Sustained

  18 Nov 2009 | 4:08 am

  Blood - November 20090 viewsNov 18, 2009

• 
  AdPharm Blog

• Pharmageddon 2012 – the end of an era for pharmaceutical marketing?

  AdPharm

  20 Nov 2009 | 3:45 am

  Have you heard of Pharmageddon 2012? If you follow the pharmaceutical industry on social media at all, it’s almost impossible not to. It’s on YouTube, Facebook, Flickr. It has it’s... Read the rest on AdPharm's blog!

• Search using colors as keywords

  AdPharm

  19 Nov 2009 | 6:15 am

  Did you know you could search pharmaceutical ads by color on AdPharm? Most of the ads in the gallery now have color tags. This can be useful when it’s time to decide on the colors for a new... Read the rest on AdPharm's blog!

• New Geodon HCP campaign

  AdPharm

  18 Nov 2009 | 10:49 am

  Brand name: Geodon Generic name/category: Ziprasidone, Atypical antipsychotic Company: Pfizer Country/Market: USA, North America Indication(s)/use: acute agitation in schizophrenic patients and acute... Read the rest on AdPharm's blog!

• Symbicort

  AdPharm

  17 Nov 2009 | 6:12 am

  Read the rest on AdPharm's blog!

• Antiphlogistine – TV commercial

  AdPharm

  16 Nov 2009 | 1:45 pm

  Read the rest on AdPharm's blog!

• 
  Pharmaceutical Online

• SinoFresh Nasal Spray Achieves Positive Results Against H1N1 (Swine Flu) Virus In Initial Pilot Animal Study

  19 Nov 2009 | 6:14 am

  SinoFresh Healthcare Products, Inc. announced today the successful results of its initial pilot animal study testing the efficacy of the SinoFresh Nasal Spray product when used on animals infected with the H1N1 ("swine flu") virus.

• Scancell Selects PharmaNet Development Group For SCIB1 Clinical Trial

  19 Nov 2009 | 6:02 am

  Scancell Holdings Plc, (PLUS:SCLP), the parent company of Scancell Limited ('Scancell'), the developer of innovative therapeutic cancer vaccines, is pleased to announce that it expects to commence its Phase I/II clinical trial with SCIB in the first half of 2010.

• PPD To Acquire BioDuro

  19 Nov 2009 | 5:37 am

  PPD, Inc. (Nasdaq: PPDI) today announced it has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company that provides a broad range of integrated services to biopharmaceutical companies. The acquisition will expand PPD's drug development capabilities in China.

• High Volume Microplate For Sensitive Photometric Assays

  19 Nov 2009 | 4:56 am

  With a well volume of 3.1ml the Krystal 24 from Porvair Science Ltd. is the microplate of choice for screening applications that require high sensitivity combined with photometric accuracy and repeatability.

• Mysteries Solved With Rheology - Fifth eLearning Course From Anton Paar

  19 Nov 2009 | 4:05 am

  The most recent addition to Anton Paar's award-winning series of interactive eLearning courses has arrived: 'Basics of Rheometry I Oscillation' follows the four previous courses about density measurement, CO2 content determination, viscometry and rotational rheometry. The CD provides a basic introduction to the science of rheological oscillatory testing.

• 
  Bioresearch Online News

• Amaizeing: Corn Genome Decoded

  20 Nov 2009 | 8:35 am

  In recent years, scientists have decoded the DNA of humans and a menagerie of creatures but none with genes as complex as a stalk of corn, the latest genome to be unraveled.

• SinoFresh Nasal Spray Achieves Positive Results Against H1N1 (Swine Flu) Virus In Initial Pilot Animal Study

  19 Nov 2009 | 6:14 am

  SinoFresh Healthcare Products, Inc. announced today the successful results of its initial pilot animal study testing the efficacy of the SinoFresh Nasal Spray product when used on animals infected with the H1N1 ("swine flu") virus.

• PPD To Acquire BioDuro

  19 Nov 2009 | 5:37 am

  PPD, Inc. (Nasdaq: PPDI) today announced it has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company that provides a broad range of integrated services to biopharmaceutical companies. The acquisition will expand PPD's drug development capabilities in China.

• High Volume Microplate For Sensitive Photometric Assays

  19 Nov 2009 | 4:56 am

  With a well volume of 3.1ml the Krystal 24 from Porvair Science Ltd. is the microplate of choice for screening applications that require high sensitivity combined with photometric accuracy and repeatability.

• Accelerating Safe Concentration Of Accelerated Solvent Extraction Samples

  19 Nov 2009 | 3:47 am

  Genevac has announced the Puck - a new sampling accessory that extends the sampling versatility of its Rocket™ Evaporator to simultaneously accommodate up to eighteen 60ml Accelerated Solvent Extractor (ASE®) tubes.

• 
  PharmiMike

• Using Social Media to Attract Passive Jobseekers

  PharmiMike

  5 Nov 2009 | 2:14 am

  Nice concise article by Cat at CK Clinical :  http://ckclinical.co.uk/news/using-social-media-to-attract-passive-jobseekers/ Related posts:Social Media ~ The Beautiful and Intelligent WomanEvent: Social Media in RecruitmentGreat Social Media Presentation!

• Bogus Candidates?

  PharmiMike

  28 Oct 2009 | 7:12 am

  Are some recruiters pretending to be candidates just to get the inside information on a job or client? We think they are! http://www.pharmiweb.com/features/feature.asp?ROW_ID=1249 Related posts:Interesting tool for candidates

• The Social Life of Health Information

  PharmiMike

  22 Oct 2009 | 2:09 am

  “American’s pursuit of health takes place within a widening network of both online and offline sources” This report from PEW Internet looks interesting.. 61% of Americans look online for health information. I’ve not read it all yet, but that will be this evening’s task http://www.pewinternet.org/~/media/Files/Reports/2009/PIP_Health_2009.pdf (PDF) Related posts:Social Media ~ The Beautiful and Intelligent WomanUsing Social Media to Attract Passive JobseekersEvent: Social Media in Recruitment

• Snowboarding with concrete cows?

  PharmiMike

  20 Oct 2009 | 3:27 pm

  yes I’m off to Milton Keynes tomorrow to go snowboarding at the SnowZone. OK, its not the real thing but at least its snow, and I haven’t been on my board since Canada last year (oh  hang on it was April this year!) Anyway – if you guys can please make sure nothing exciting happens until I get back! No related posts.

• Novartis Oncology using video to recruit

  PharmiMike

  20 Oct 2009 | 2:45 am

  Novartis Oncology have launched a great recruitment campaign using employee video testimonials as the focus. Its called the Open Employee Generation campaign: Year after year, companies try to attract top talent with want ads and job descriptions that show off the company, but don’t explain why talent should want the job.  Which is why, with hundreds of positions to fill in 2009, Novartis Oncology is overhauling its strategy for attracting and hiring top talent by letting its employees tell job applicants exactly why they enjoy coming to work for the leading oncology company every day.

• 
  Pharma News from PharmiWeb.com

• Merck Serono: CHMP Opinion for Erbitux in Advanced Non-Small Cell Lung Cancer

  19 Nov 2009 | 5:00 pm

  Merck Serono: CHMP Opinion for Erbitux in Advanced Non-Small Cell Lung CancerGeneva, Switzerland, November 19, 2009 –...Merck Serono

• 2009/069 NICE appraisal of sorafenib for advanced hepatocellular carcinoma

  19 Nov 2009 | 5:00 pm

  2009/069 NICE appraisal of sorafenib for advanced hepatocellular carcinomaThe National Institute for Health and Clinical Excell...NICE

• Archimedes Pharma wins the Scrip Award for SME Pharma Company of the Year

  19 Nov 2009 | 5:00 pm

  Archimedes Pharma wins the Scrip Award for SME Pharma Company of the YearREADING, UK, 20 November 2009 – Archimedes P...Archimedes Pharma Limited

• AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor), an Investigational Antiplatelet Agent

  19 Nov 2009 | 5:00 pm

  AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor), an Investigational Antiplatelet AgentAstraZeneca today a...AstraZeneca

• Company Statement

  18 Nov 2009 | 5:00 pm

  Company StatementNewbury, 19 November 2009: Bayer Healthcare today confirmed that it is to appeal the decision by NICE to deny ...Bayer Schering Pharma

• 
  Pharmaceutical Business Review

• Grassroots Chemical Security Letters Help Persuade Congress, Says Socma

  18 Nov 2009 | 10:30 pm

  The letters explained the negative impacts of the Inherently Safer Technology (IST) provision

• Bayer MaterialScience Aquires PolyBioMed

  17 Nov 2009 | 10:30 pm

  To provide materials that enhance design, manufacturing and end-use performance for products

• Dow Publishes New Company Databook - The Elements Of Success

  17 Nov 2009 | 6:13 pm

  Inaugural edition provides comprehensive insight into Dow as a specialty chemicals and advanced materials company

• SOCMA Urges Congress To Take Risk-Based Approach To TSCA Reform

  16 Nov 2009 | 3:38 pm

  Urges Congress to avoid sweeping changes to the Toxic Substances Control Act

• Torrent Pharma Plans New Investments

  15 Nov 2009 | 1:27 pm

  Company eyes regulated drug markets

• 
  EuroPharma Today

• Financings of the Fortnight Has European Flavor

  Sean

  20 Nov 2009 | 1:41 am

  This morning the Belgian J&J spin-out Movetis said it filed to raise up to more than €112 million in what could be Europe's first biopharma IPO since Italian biotech Molmed raised €56 million in February 2008.

• DeCode Enters Bankruptcy, Looks To Sell Assets To Its Former VCs

  Sean

  18 Nov 2009 | 4:26 am

  Icelandic biotech DeCode Genetics filed for Chapter 11 bankruptcy Nov. 16, likely signaling the end of one of the last surviving firms created during the genomics bubble at the end of the previous decade.

• Dutch Biotech PanGenetics Secures $170m u/f in Abbott Deal

  Sean

  13 Nov 2009 | 8:48 am

  Abbott will pay Dutch antibody developer PanGenetics $170 million upfront for the global rights to a humanized antibody to nerve growth factor in Phase I clinical development for osteoarthritis. The agreement, announced Nov. 12, positions Abbott as a contender in a race to develop an NGF antibody for pain.

• Glaxo Taps Astex for Fragment-Based Discovery Deal Worth At Least $33 Mil.

  Sean

  13 Nov 2009 | 8:41 am

  British biotech Astex Therapeutics landed a sizeable discovery deal with GlaxoSmithKline that comes as a surprise on two fronts: the big drug maker is guaranteeing $33 million, and the deal doesn't include options, which recently has been Glaxo's preferred method of discovery-stage deal-making.

• UK Gov't Outlines Hands-Off Approach to Boosting VC

  Sean

  13 Nov 2009 | 8:38 am

  You thought the VC model was broken? Not according to the UK government, which today provided further detail on its plans to support an innovation-focused fund-of-funds to invest in VC funds covering life sciences, clean-tech and digital tech over a 12-15 year period.

• 
  Medical-Brochures.blogspot

• Generation RX Part 1

  14 Nov 2009 | 2:20 pm

  http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.

• ePharma Summit 2009 Day 1 Panel: How Can Pharma Companies More Effectively Reach MDs Online?

  14 Nov 2009 | 2:11 pm

  http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.

• Pharma Marketing with Meaning Pecha Kucha from Dose of Digital

  13 Nov 2009 | 10:08 am

  http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.

• Dr Rauni Kilde on Swine Flu Conspiracy

  4 Nov 2009 | 2:21 pm

  http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.

• Advanced Pharmaceutical Sales Training

  29 Oct 2009 | 2:49 pm

  http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.

• 
  Impactiviti

• Impactiviti Daily 112009

  Steve Woodruff

  20 Nov 2009 | 6:15 am

  TODAY’S NEWS So, have we been pursuing the wrong course for GERD all this time? Is it actually caused by immune system cells, not stomach acid? Maybe cheap/old/tried-and-true really is better. Diuretics for HPB, for instance. Or just plain generic simvastatin for cholesterol. Pfizer gets good news on Revatio (which is the same as Viagra, by the way) for the treatment of PAH; Spiriva for COPD; and the Prevnar 13 vaccine. Genzyme: Train wreck?. But wait – there’s more. Getting excited about sex: not so easy to be excited about B-I’s experimental treatment for female desire;…

• Impactiviti Daily 111709

  Steve Woodruff

  17 Nov 2009 | 4:53 am

  Whew! The back-to-back conference marathon is now over, and we can get back to our regular pharma news reporting. Here’s what’s up today… TODAY’S NEWS Everyone’s talking about the Zetia/Niaspan study – its results, its significance, its limitations. Bottom line – I can’t see how this can be good for Merck. More here. And Jim Edwards analyzes the damage control spin effort here. Always a headline topic: female sexual desire treatments. The more you read about this drug (experimental ‘flibanserin’ from Boehringer-Ingelheim), however, the…

• The Pitfall of Doing Nothing

  Steve Woodruff

  3 Nov 2009 | 12:53 pm

  [I'm talking pharma here. But just swap in your industry and the argument will likely apply!] Here in the highly regulated prairies of pharma-land, there is a fair amount of fear and trembling about drug companies getting involved with social networking. Many of the discussions start and end with the perceived potential pitfalls (lots of which are actually red herrings). What if a patient talks about an adverse event with our drug? How can we “talk” directly to patients? What if there is off-label discussion? Is it a form of marketing? What’s the ROI? What will the FDA…

• Impactiviti Daily 110209

  Steve Woodruff

  2 Nov 2009 | 5:38 am

  TODAY’S NEWS Takeda buys into Amylin’s weight-loss drug portfolio – Takeda will pay $75 million upfront for medicines including Amylin’s pramlintide/metreleptin and davalintide, in the second phase of testing needed for U.S. regulatory approval, Osaka- based Takeda and San Diego-based Amylin said in a statement…more Plus, quickie update on three other anti-obesity drugs being developed by various companies. New lupus treatment (HGS/Glaxo) looking promising on pathway to approval – Human Genome Sciences Inc said its experimental lupus drug Benlysta was successful in…

• Impactiviti Daily 103009

  Steve Woodruff

  30 Oct 2009 | 5:18 am

  TODAY’S NEWS FTC says “yes” to Merck-Schering merger. AstraZeneca’s experimental drug Brilinta may not get along well with aspirin: AstraZeneca Plc is looking into whether greater use of aspirin reduces the effectiveness of its experimental clot-busting medicine Brilinta, which analysts had estimated would bring in $1 billion a year…more Plus, AZ agrees to a $520M fine in Seroquel marketing probe. Ouch. Medical Marketing and Media agency awards for this year. It was an in-house effort that picked up the Gold Award for Best Integration Program for Large Companies. Statins…

• 
  Hooked: Ethics, Medicine, and Pharma

• No Fair Peeking? More Questions about Early Stopping of Trials

  18 Nov 2009 | 9:56 am

  In the previous post I mentioned the recent findings about ezetimibe, which happened to be part of the study called ARBITER 6. As one evidence-based blogger, Dr. David Rind has noted--http://www.evidenceinmedicine.org/2009/11/arbiter-6-and-combining-therapies-with-statins.html--the results as published could be consistent with three different possibilities:Ezetimibe adds nothing to heart disease prevention; niacin is helpfulNiacin is slightly helpful or neutral and ezetimibe actually worsens arterial plaqueAll the results of the study are due to chance aloneOption #3 becomes meaningful when…

• More Bad News on Ezetimibe--So Why Do We Still Take It?

  16 Nov 2009 | 5:17 pm

  In the past I did several posts on the ENHANCE trial (like, http://brodyhooked.blogspot.com/2008/01/now-that-weve-been-enhanced-whats.html) that showed that ezetimibe (Zetia, Vytorin) was a flop at reducing cholesterol containing plaque within arteries.The news this week is the New England Journal study--http://content.nejm.org/cgi/content/full/NEJMoa0907569--in which ironically ezetimibe (Zetia) was stabbed in the back by a competing drug company, Abbott, promoting its own drug, extended-release niacin. A head-to-head trial indicated not only that niacin was better at reducing arterial…

• More on Suppression of Unfavorable Trial Results--and a Warning Note

  14 Nov 2009 | 11:51 am

  If I had not gotten off onto the COI tangent in recent posts, the big news of the week would probably have been the publication in the New England Journal of the paper by Vedula et al. on selective outcome reporting for gabapentin.The quick once-over is that in order to reveal how research sponsored by pharmaceutical companies sometimes undergoes selective publication or suppression of data, to favor marketing the company's drug, you need both the publication itself (the "after") and some snapshot of the actual research data in its more-closely-raw state (the "before"). (Or, to show that the…

• COI: Further Response from Stell

  14 Nov 2009 | 7:14 am

  Folks, I trust this will be the last post on this particular exchange; any further discussion will be relegated to comments to posts. However, I think the topic is well worth the headlines because the definition of "conflict of interest" is central to our discussion--if we do not know what COI is, then much of the rest of our ethical concerns fall down. (Hence the shrewdness of a counterstrategy that attacks the definition directly.)Lance Stell has kindly replied to my most recent post (one down) as follows:...here’s how I summarize your [Brody's] response.· Langbein is sensible, but is…

• COI: My Reply to Stell

  13 Nov 2009 | 6:07 pm

  In the last post I turned the microphone over to my esteemed colleague, philosopher and bioethicist Lance Stell. He apparently accepted the definition of 'conflict of interest' attributed to him in the editorial by Michael Weber that was the subject of the post immediately preceding. He then proceeded to offer a further defense of that definition of COI, and cited as his inspiration for that definition the work of a Yale law professor, John Langbein.I have now spent a pleasant couple of hours reading the 63-page article by Langbein that Prof. Stell refers us to. My conclusion is that it makes…

• 
  FDA Law Blog

• FDA Denies Galderma Petition on QI Act 30-Month Stay Issue

  FDABlog HPM

  20 Nov 2009 | 6:25 am

  By Kurt R. Karst – In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval on an ANDA referencing the old antibiotic drug product ORACEA (doxycycline) if that ANDA contains a Paragraph IV certification to a patent that was listed in the Orange Book in accordance with § 4(b)(1) of the QI Act.  The QI Act amended the FDC Act to add § 505(v) to create Hatch-Waxman benefits for “old” antibiotics.  FDA…

• FDA’s Hearing on Social Media – More Questions, No Answers

  FDABlog HPM

  19 Nov 2009 | 11:09 am

  By Dara Katcher Levy On November 12 and 13, FDA held a Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.  The hearing represents FDA’s second attempt at gathering information on using the internet to promote medical products – the first taking place in October 1996.   As we all are keenly aware, FDA did not issue any guidance to industry on the use of the internet as a result of that meeting. The 12 member FDA panel listened to about 78 presenters over the course of two days.  Although the panel asked a few questions, they made…

• Proposed legislation to secure insurance coverage for certain medical foods could eliminate coverage for others

  FDABlog HPM

  19 Nov 2009 | 11:09 am

  By A. Wes Siegner, Jr. and Ricardo Carvajal   Sen. Kerry has introduced the Medical Foods Equity Act of 2009 with the goal of securing insurance coverage for certain medical foods.  The legislation would secure coverage under federal insurance plans (e.g., Medicaid and Medicare), plans governed by the Employment Retirement Income Security Act (ERISA), and plans on the individual and group markets for the following types of food: medically necessary food and food modified to be low protein that is  formulated to be consumed or administered under the supervision of a qualified medical…

• Hyman, Phelps & McNamara, P.C. Announces Two New Directors

  FDABlog HPM

  17 Nov 2009 | 5:41 am

  Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation.  Mr. Karst focuses primarily on Hatch-Waxman and drug development issues. 

• Center for Tobacco Products to offer training on eSubmitter

  FDABlog HPM

  16 Nov 2009 | 11:54 am

  By David B. Clissold and Ricardo Carvajal The Center for Tobacco Products has scheduled a web-based training session on use of the eSubmitter program to electronically submit establishment registration and product listing information (see here).  Submission of that information by December 31 is required under FDCA section 905.  Those who are interested in participating are directed to provide their Company name and contact information to eSubmitter@fda.hhs.gov by noon on Wednesday, November 18.  FDA advises that, in the absence of sufficient interest, the training may be cancelled.

• 
  RxBlog (tm) .net / Health + Drug Blog

• Obama Declares Swine Flu a National Emergency

  Primary Editor

  25 Oct 2009 | 9:59 am

  He is clearing the way for legal waivers to allow hospitals and doctors offices to better handle a surge of new patients. » Rx Blog [ Contribute: submit link / submit article ]

• Swine Flu Shots Revive a Debate About Vaccines

  Primary Editor

  16 Oct 2009 | 7:05 am

  People who do not believe in vaccinating children have never had much sway over Leslie Wygant Arndt. She has studied the vaccine debate, she said, and came out in favor of having her 10-month-old daughter inoculated against childhood diseases. But...

• Skin cancer can be inherited: studies

  Primary Editor

  11 Oct 2009 | 6:50 am

  Want to reduce your risk of skin cancer? Wear sun screen, of course. But two new studies suggest that choosing your relatives carefully could also be helpful. One found that having an identical twin with melanoma increased a person's own risk of...

• Swine flu is present 'in virtually the entire country,' CDC expert says

  Primary Editor

  10 Oct 2009 | 9:00 am

  Pandemic H1N1 influenza "is here . . . in virtually the entire country," Dr. Anne Schuchat of the Centers for Disease Control and Prevention said Friday. Swine flu is widespread in 37 states now, up from 27 states last week, she said. The figures...

• Cancer Spreading Gene Discovered

  Primary Editor

  6 Oct 2009 | 4:54 am

  Scientists have pinpointed a gene linked to more than half of all breast cancers. The gene, NRG1 (neuregulin-1), is also thought to play a role in many bowel, prostate, ovarian and bladder tumours. The University of Cambridge team said the...

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  PHARMACOSERÍAS Marketing Farmacéutico/Pharmaceutical Marketing

• Ratón de biblioteca...: LO SIENTO MUCHO Lobo Antunes

  19 Nov 2009 | 3:05 pm

  En cada uno de los profesionales de la medicina se esconde el deseo de ser perfectos, casi santos, de estar por encima de cualquier cosa. Pero en su experiencia los médicos arrastran una pesada carga de innumerables miradas, sonidos, olores y otros muchos instantes que a menudo los hacen sentirse pequeños e imperfectos. Lo siento mucho es un libro de testimonios conmovedor.Una hermosa y profunda

• "Big Pharma": Los ricos tambien compran...

  19 Nov 2009 | 3:04 pm

  Clik sobre imagen para ampliar...A tale of three drugmakersJohnson & Johnson, the company with the most cash of those listed, is taking on a new strategy to build its pipeline. As an alternative to the conglomerate's usual strategy of acquiring companies and bolting them on, CEO William Weldon says the company will continue to use its new tactic of sharing risk through partnerships, like

• The Worst Drug Company Marketing Techniques (IV): BMS

  19 Nov 2009 | 3:03 pm

  In 2007, Bristol-Myers Squibb settled with the U.S. Department of Justice on a number charges, which included unlawful marketing of pharmaceuticals, illegal pricing, and offering kickbacks to health care providers. BMS allegedly promoted one of its drugs, the anti-psychotic Abilify, for unsanctioned use in treating dementia and children. As a result, the New York drug company was fined $515

• Comisión Europea y Sector farmacéutico (V): INFORME

  19 Nov 2009 | 3:02 pm

  Se puede descargar...Ver anteriores...

• Novartis: "de la misa la media..." con vacuna AH1N1

  18 Nov 2009 | 3:05 pm

  El laboratorio farmacéutico suizo Novartis anunció el jueves (septiembre 3, 2009) que una de sus vacunas para la gripe porcina podría surtir efecto con una sola dosis en vez de dos como se suponía, un hallazgo que podría incrementar el suministro mundial. (Ver...)ZURICH (Reuters) (noviembre 17, 2009)-A U.S. clinical study suggests that just half a dose of the Novartis AG H1N1 vaccine may be